Results

Aimmune Therapeutics Inc.

11/08/2019 | Press release | Distributed by Public on 11/08/2019 10:03

Quality of Life Outcomes from Two New Surveys Highlight Emotional Impact of Peanut Allergy and Need for New Treatments

-New Data at ACAAI Reinforce the Need for Treatments to Reduce the Fear of Accidental Exposure to Peanut and Improve Emotional Well-Being for Adult Patients and Caregivers-

HOUSTON--(BUSINESS WIRE)--Nov. 8, 2019-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today presented results from two new surveys that examined the effects of peanut allergy on health-related quality of life (HRQoL) among adults and caregivers in the United States. The findings reinforce the need for new treatments in peanut allergy that may reduce concerns related to peanuts, decrease the potential risk of allergic reactions and improve the HRQoL of those impacted by peanut allergy: adult patients, children and their caregivers. These survey results were presented at the American College of Asthma, Allergy and Immunology (ACAAI) Annual Scientific Meeting in Houston.

Peanut allergy is one of the most common food allergies, affecting more than 6 million people in the U.S. and Europe.Given the potential severity of symptoms and need for close management, living with food allergies such as peanut allergy presents day-to-day concerns and challenges for allergic individuals and their families, and this can negatively affect health-related quality of life (HRQoL).1,2,3

'While there is a fair amount of literature on the burden of food allergy and how it impacts patients, these data shed further light on the hardship faced among those impacted by peanut allergy, while underscoring the need for a treatment option beyond avoiding peanuts alone,' said William McCann, MD, study author and Vice President, Chief Medical Officer and physician owner of Allergy Partners, the largest single-specialty allergy practice in the US, focusing on treating asthma and allergic disease with locations across 20 states.

Survey Results Among Adult Patients
In a survey of 150 peanut allergic adults, the mean age of participants was 31.4 years and 64.1% were white. According to results, two-thirds of peanut allergic adults felt the fear of experiencing a reaction affected their emotional well-being 'completely' (13.1%), 'very much' (23.5%) or 'somewhat' (30.1%), indicating a high degree of fear related to peanut allergy reactions.

'Living with a food allergy such as peanut allergy is associated with day-to-day concerns and challenges for many if not most adults, as well as their families, and negatively impacts their quality of life,' said Anna Nowak-Wegrzyn, MD, PhD, study author and Director, Division of Pediatric Allergy and Immunology, New York University School of Medicine, NYU Langone Health, New York, NY. 'Given the potential severity of symptoms and need for close management, these findings further point to the need to help improve the emotional well-being of peanut allergic adults with robust support programs and treatment options.'

Survey Results Among Caregivers
Examining the peanut allergy-related concerns and health-related quality of life of caregivers and their children with peanut allergy from the perspective of the caregiver, a separate survey includes insights from approximately 400 caregivers of people with peanut allergy aged one to seventeen years old, with a mean age of 9 years. The outcomes showed that more than one-third felt 'not at all' to 'somewhat' in control of their child's peanut allergy, and almost one-third reported they were 'not at all' to 'somewhat' confident in managing their child's peanut allergy reactions.

Furthermore, the survey revealed that more than two-thirds of caregivers felt that the fear of their child experiencing a reaction to peanuts affected their own emotional well-being, and two-thirds also felt that their fear limited their own day-to-day activities. The majority of caregivers (70%) also reported that peanut allergy affected their child's day-to-day life 'somewhat' to 'completely.'

About Aimmune
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral treatments for potentially life-threatening food allergies. The Company's Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune's first, investigational, complex biologic product candidate, AR101, is being developed as a treatment to reduce the frequency and severity of adverse events following exposure to peanut. The Biologics License Application (BLA) for AR101 is under review by the U.S. Food and Drug Administration (FDA), which granted AR101 Breakthrough Therapy Designation in 2015 for the desensitization of peanut-allergic patients 4 to 17 years of age. The European Medicines Agency (EMA) is reviewing Aimmune's Marketing Authorization Application (MAA) for AR101 which Aimmune submitted in June 2019. Aimmune initiated a randomized phase 2 clinical trial of its second investigational, complex biologic product, AR201, for the treatment of egg allergy in August 2019. For more information, please see www.aimmune.com.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act 'of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune's expectations regarding the potential benefits of AR101; and Aimmune's expectations regarding potential applications of the CODIT™ approach to treating potentially life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; the unpredictability of the regulatory process; the possibility that Aimmune's or any of its collaborative partners' clinical trials will not be successful; Aimmune's dependence on the success of AR101; Aimmune's reliance on third parties for the manufacture of Aimmune's product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This press release concerns AR101 and AR201, product candidates that are under clinical investigation. Neither AR101 nor AR201 has been approved for marketing by the FDA or the EMA. AR101 and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.

References
1 Cummings AJ, Knibb RC, King RM, et al. Allergy. 2010;65(8):933-945.
2 King RM, Knibb RC, Hourihane JB. Allergy. 2009;64(3):461-468.
3 Primeau MN, Kagan R, Joseph L, et al. Clin Exp Allergy. 2000;30(8):1135-1143.

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Source: Aimmune Therapeutics, Inc.

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